PROBLEM STATEMENT

Client 1: Project 1: A renowned large consulting company needed a consultant to perform FDA 483 Commitment Verifications for one of their Large Global Pharma Clients to ensure that all the FDA commitments were adequately completed, and FDA update packages were prepared. Project 2 and 3: A consultant was needed for the 2 different clients for warning letter Global remediation plan commitment verification to ensure all the commitments were completed as defined in remediation plan.

Client 2: A small consulting company needed a consultant to review FDA 483 and WL’s responses to verify that responses were adequate and to identify any additional gaps in the responses to adequately address the root cause and remediate the observation.

EXPERTISE AND SOLUTIONS

Client 1: Project 1: The client company hired one of the principal consultants from PJI Biotech to complete the project 1 over 6 months. Our consultant worked directly with the Global Pharma client to review all the 483 and WL, issued by the FDA and also the compliance history to understand the issues. Global Pharma client provided all the evidence documents for the FDA commitments. All the evidence documents (Study plan, study reports, results, data, associated procedures, CAPA, CAPA effectiveness, etc.) were reviewed to ensure that all the commitments were completed as defined in FDA responses, met the committed timeline, and that implemented CAPA was effective. In addition, FDA update packages were prepared for submission. 

Project 2 and 3: Our principal consultant was hired for global remediation plan commitment verification by 2 different clients. Our consultant reviewed remediation plan and worked with the site quality for 6-7 different sites to verify the implementation of remediation plan.  All the evidence documents, CAPA, global procedures, local and global quality systems and related documents were reviewed to verify the remediation plan implementation. Based on the review of documents, a quality advice and oversight was provided to ensure that all the commitments were adequately completed over the period of 12-18 months.

Client 2: The client company hired one of the principal consultants from PJI Biotech to complete the project within one month. The client provided all the 483, 483 responses, WL, WL response, FDA update documents, data, study reports, procedures, and other associated evidence documents. All the documents were reviewed to ensure that marketed product assessments were adequate, interim controls were identified, root cause of observation was conducted, systemic issues were identified and appropriate CAPA were identified to remediate root cause and systemic issue.  Additional CAPA were identified to ensure that the FDA observation was adequately addressed to holistically remediate the issue and prevent the recurrence of the issue. The gap assessment report was generated and provided to the client (consulting company).

RESULTS

Client 1: As a result, the Global Pharma Company client was able to submit the FDA updates every month, for several months, while ensuring CAPA effectiveness for project 1. Similarly, project 2 and 3 were completed successfully to ensure and verify the implementation of remediation plan.

Client 2: As a result, the consulting company was able to provide the gap assessment report to their client (a small pharma company).

FEEDBACK

The client firms was very appreciative of the support provided, dedication, flexibility, and meeting their objectives.